BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2930275 · Received January 25, 2013

    Report

    Report Number
    3008382007-2013-01478
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LIFESCAN UK ON (B)(6) 2013, ALLEGING AN ERROR 5 MESSAGE ON THEIR ONE TOUCH ULTRA EASY METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT MENTIONED THAT THEY HAD OBTAINED THE ERROR 5 MESSAGE FOR THE PAST WEEK. DUE TO THE ALLEGED ERROR 5 MESSAGE, THE PATIENT DOES NOT REMEMBER WHETHER OR NOT THEY TOOK THEIR DIABETES MEDICATION ON A REGULAR BASIS. THE PATIENT TAKES INSULIN AND TESTS AT LEAST 3X A DAY. ON (B)(6), AT NOON, THE PATIENT ATE AND 15 MINUTES LATER FELL UNCONSCIOUS. IT WAS MENTIONED THAT AT AN UNSPECIFIED TIME LATER THE NEIGHBOR FOUND THE PATIENT AND THE PATIENT REGAINED CONSCIOUSNESS THREE HOURS LATER. THE PATIENT WAS NOT TREATED PRIOR OR AFTER REGAINING CONSCIOUSNESS. THE PATIENT WAS NOT TESTED ON ANOTHER DEVICE AND THE PATIENT CONTACTED HIS PHYSICIAN DUE TO THE ALLEGED ISSUE AND DID NOT RECEIVE ANY MEDICAL TREATMENT. IT WAS NOTED WHILE TROUBLESHOOTING THAT THE TEST STRIPS THE PATIENT HAD BEEN USING WAS EXPIRED AND THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS PER THE OWNER'S BOOKLET AN ERROR 5 MEANS THAT THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE ERROR 5 MESSAGE, THE PATIENT WAS UNABLE TO TEST AND APPROXIMATELY A WEEK LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35754 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3205128

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening